跳至主要内容
临床试验/NL-OMON49829
NL-OMON49829招募中2 期

Preserved platelet function during cardiopulmonary bypass with aprotinin in dual antiplatelet therapy. - Aprotinin study

Isala Klinieken0 个研究点目标入组 58 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
58

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • 1. Eighteen years of age or older.
  • 2. Undergoing elective on-pump coronary artery bypass surgery.
  • 3. Use of a combination of aspirin and clopidogrel until at least 3 days prior

排除标准

  • 1. Positive pregnancy test, pregnancy or lactation.
  • 2. Women of child-bearing age not using a medically approved method of
  • contraception during the study.
  • 3. Undergoing an emergency operation.
  • 4. Proof or suspicion of a congenital or acquired coagulation disorder (e.g.
  • VWD or via severe liver disease).
  • 5. Apoplexy in the 2 months preceding study surgery.
  • 6. Manifest venous or arterial thrombosis.
  • 7. Medication:
  • o Tirofiban administration in the 2 days preceding surgery.
  • o INR >1.4 if on coumadines.
  • 8. Participation in another clinical study in the 4 weeks preceding this study.
  • 9. Having received aprotinin in the last 2 months, in the absence of a IgG
  • antibody test
  • 10. Renal dysfunction, defined as eGFR <45 (mL/min/1.73m2)
  • 11. Sensitivity to any of the components of study medication.
  • 12. Any indication that the restrictions or procedures of the study may not be
  • adhered to (e.g. an uncooperative attitude).
  • 13. Any indication that the study restrictions, procedures, or consequences
  • therein have not been considered or understood, such that informed consent
  • cannot be convincingly given.
  • 14. Multiple morbidities, with a notably constrained remaining length of life.

研究者

发起方
Isala Klinieken

相似试验

Preserved platelet function during cardiopulmonary... | 临床试验